Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives. (Estradiol/MAM)
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|ClinicalTrials.gov Identifier: NCT01251263|
Recruitment Status : Unknown
Verified October 2010 by Scott and White Hospital & Clinic.
Recruitment status was: Recruiting
First Posted : December 1, 2010
Last Update Posted : December 1, 2010
This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental estradiol therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAMs). The subjects enrolling in the study will have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs, the subject will institute a 4-day hormone-free interval (HFI). In an attempt to prevent/lessen the severity of headache during the HFI, subjects will be randomized to oral estradiol or placebo during this period. If no BTB/BTS occurs after 80 days of continuous pills, the subject will institute a 4-day HFI during which they will be randomized into estradiol or placebo groups.
The purpose of this research study is to examine the effects of continuous oral contraceptive pills and oral estradiol on headaches that occur around the time of your period. Many woman take continuous oral contraceptive pills (OC) and when OCs are stopped they may get headaches. This study will examine if taking estradiol around the time of the period will affect the headache, and how it will be affected.
This study is a prospective trial. A subject's participation will last approximately 32 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Menstrual Migraines Menstrual Bleeding Menstrual Spotting||Drug: Estradiol or Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||October 2012|
Cyclic OC users prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.
Drug: Estradiol or Placebo
Estradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses).
Spontaneous ovulation group prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.
Drug: Estradiol or Placebo
Estradiol 1mg will be taken twice daily starting with the last day of pills and the 4 days of the HFI(total of 9 doses)
- Primary Outcome Measure [ Time Frame: 32 weeks ]Comparing baseline menstrually associated migraines(MAMs) to headache occurance and severity after the implementation of continuous OC therapy.
- Secondary Outcome Measure [ Time Frame: 32 weeks ]Compare effect of estradiol versus placebo on MAMs severity and duration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251263
|Contact: Wendy M White, CCRPfirstname.lastname@example.org|
|United States, Texas|
|Scott and White Hospital & Clinic||Recruiting|
|Temple, Texas, United States, 76508|
|Principal Investigator: Patricia J Sulak, MD|
|Principal Investigator:||Patricia J Sulak, MD||Scott and White Healthcare|